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On July 10th and 11th, the Obstetrics and Gynecology Devices Panel of the Food and Drug Administration’s Medical Devices Advisory Committee met to discuss the safety of power morcellator devices and their common use in laparoscopic hysterectomy and myomectomy. More specifically, the committee addressed the use and potential risks of power morcellation to spread and upstage undetected uterine cancer during these procedures and will make recommendations for appropriate use, required testing and labeling, and other risk mitigations for these devices.
Open to the public, the meeting gave anyone interested the opportunity to present pertinent information or opinions in oral or written form during the general open public hearing session, between 9am and 10am. For more information, please visit the FDA Calendar of Public Meetings.
The meeting was a necessary outcome following the FDA’s April safety communication and Ethicon’s subsequent decision to suspend sales of the devices. The advisory notice strongly discouraged the use of power morcellators during laparoscopic myomectomy and hysterectomy due to rising evidence of the risk for power morcellation to disseminate not only benign tissue, causing further complications, but also to spread and upstage uterine sarcomas that are, as the FDA concluded, nearly impossible to detect preoperatively. The meeting agenda consisted of an open public hearing, presentations by cancer specialists and industry speakers invited by the FDA, an FDA presentation, and an FDA question and panel deliberation.
A majority of panelists advocated for an update to the packaging of power morcellators that would include a black box warning label, and for a reclassification of the devices to Class III, the strictest device category, which requires pre-market approval.
While an overall consensus was not reached, as some panelists were against an “outright ban” and others wanted the device removed from the market completely, it was agreed that the black box warning alone would be insufficient in protecting patients. The panelists recommended that women and their doctors should be required to sign a written consent form that details the risk of power morcellation to disseminate benign and undetected malignant tissue during laparoscopic hysterectomies and myomectomies. Women and family members of those who died from cancer following a power morcellation procedure gave emotional testimonies, stating that they were never informed of these risks.
The FDA moderator made a point to emphasize that although these options of risk mitigation are being considered, a ban on power morcellators is not being ruled out. Panelists also stressed the importance of advocating for alternatives to laparoscopic surgery when possible, such as vaginal hysterectomy, which the American College of Obstetricians and Gynecologists claims is the preferred option. Surgeons at Newton Wellesley Hospital have launched a study to see if a new inflated bag technique will eliminate the risks of power morcellation, but some panelists remain concerned that these techniques will come with a host of new issues.
The FDA announced at the meeting’s conclusion that the docket for comments regarding this issue remains open to the public.